Obtain opinions in 3 simple steps

Provide your objectives

Select the market(s)

Obtain validated insights

Use Case

Assessment of why PMDA (Japan) may request Clinical Trial Data in some situations versus Clinical Investigation Data for the same product

A large medical device manufacturer, faced one frustrating challenge while seeking approval for antimicrobial central venous catheters and antimicrobial dressings in Japan. There seemed to be an inconsistency in the Pharmaceuticals and Medical Devices Agency.

Frequently Asked Questions

Q: What is RegDesk Peer?

A: RegDesk Peer is an expert-sourced and peer-reviewed method of getting in-depth insights and answers to all your regulatory questions through leading regulatory consulants.

Q: What is the difference between RegDesk Peer and Medical Device Regulatory Consulting Company?

A: There is a significant difference between the two. Medical device regulatory consulting companies provide a single opinion, which you may have to go verify. Also, you may not have full visibility to the consultant providing the advice. It’s like a black box where you feed in significant time, money and proprietary information to get lackluster results. The approach can be risky.

Through RegDesk Peer, you eliminate the need for verifying advice. You save significant time and cost by obtaining multiple validated opinions from local consultants with the right domain expertise

Q: How can I use RegDesk Peer?

A: All you need to do is provide your questions and objectives and select the markets.

Q: How many consultants are engaged for each question?

A: You can specify the number of opinions you would like to receive. However, most clients are happy with 3 consultants.

Q: Do I get to select the consultants?

A: RegDesk Peer works seamlessly once you submit your questions. Our system selects the best suited consultants based on location and domain expertise. You will have full visibility to the consultants who contributed to your project.

Q: How long will it take to get my answers?

A: Once you have submitted all the details about your questions, you can expect to receive answers within 2 – 3 weeks.

Q: Will I have information about the qualification of the consultants?

A: Absolutely. We believe in empowering our clients with transparency and insights. You will have access to the professional credentials of the consultants.

Q: How experienced are the consulants?

A: Upon reviewing the report if you feel you would like to speak to a consultant, we can certainly make that happen. We will arrange those calls with the consultants.

Q: How much does RegDesk Peer cost?

A: The pricing is variable depending on the depth of your inquiry and the markets selected. Our cost is comparable to that of consulting companies where you obtain a single opinion. Get a free quote!